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Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma

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ClinicalTrials.gov Identifier: NCT00768157
Recruitment Status : Unknown
Verified February 2009 by Sun Yat-sen University.
Recruitment status was:  Recruiting
First Posted : October 7, 2008
Last Update Posted : February 9, 2009
Sponsor:
Information provided by:
Sun Yat-sen University

Tracking Information
First Submitted Date  ICMJE October 6, 2008
First Posted Date  ICMJE October 7, 2008
Last Update Posted Date February 9, 2009
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
Overall survivals [ Time Frame: 2,3,5years ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2008)
Recurrence rate [ Time Frame: 2,3,5years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of Antiviral Therapy After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Official Title  ICMJE Efficacy of Antiviral Therapy With Lamivudine or Entecavir After Radical Resection for Hepatitis B Virus-Related Hepatocellular Carcinoma
Brief Summary Most hepatocellular carcinomas are associated with hepatitis B virus, it is hypothesized that anti-viral treatment may be helpful in treating HBV-related hepatocellular carcinoma.
Detailed Description As we know, recurrence and metastasis could happen in hepatocellular carcinoma even after radical resection.One reason is that virus hepatitis B could be one factor contributing to the carcinogenesis of hepatocellular carcinoma.To investigated whether anti-viral therapy could improve the efficacy of radical resection of hepatitis B virus (HBV)-related hepatocellular carcinoma(HCC),we planed to conduct this clinical trial.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Hepatocellular Carcinoma
  • Hepatitis B Virus
  • Recurrence
Intervention  ICMJE
  • Drug: antiviral treatment (lamivudine or entecavir)
    antiviral treatment (lamivudine 100mg per day or entecavir 0.5mg per day)
  • Procedure: radical resection of HBV-related HCC
    Procedure/Surgery - radical resection of HBV-related HCC
Study Arms  ICMJE
  • Experimental: antiviral group
    Drug: antiviral treatment(lamivudine or entecavir) after the Procedure/Surgery (radical resection of HBV-related HCC)
    Interventions:
    • Drug: antiviral treatment (lamivudine or entecavir)
    • Procedure: radical resection of HBV-related HCC
  • Active Comparator: control group
    Procedure/Surgery (radical resection of HBV-related HCC) without Drug of antiviral treatment - close observation without antiviral treatment
    Intervention: Procedure: radical resection of HBV-related HCC
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: October 6, 2008)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2010
Estimated Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. patients who did not receive antiviral therapy prior to the resection of hepatocellular carcinoma
  2. patients who underwent radical resection of HCC, and 1 month after surgery,dynamic computed tomography showed on lesion in the liver and no signs of extrahepatic metastasis.
  3. hepatitis B surface antigen should be positive before surgery HBV-DNA level between 100000 copies/ml and 10000000copies/ml anti-HCV negative

Exclusion Criteria:

  1. previous history of antiviral therapy
  2. a baseline serum alanine aminotransferase level 2.5 times the ULN or higher
  3. positive for anti-HCV or anti-HIV
  4. Child-Pugh classification B or C after surgery
  5. preexisting evidence of hepatic decompensation, including encephalopathy,ascites,a bilirubin level more than 2 times the ULN, or a prolonged prothrombin time of more than 3 seconds
  6. signs showing recurrence or metastasis oen month after surgery
  7. underlying cardiac or renal diseases
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00768157
Other Study ID Numbers  ICMJE SYSUCC-HCC004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Cancer Center of Sun Yat-sen University
Study Sponsor  ICMJE Sun Yat-sen University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jin-Qing LI, Ph.D Sun Yat-sen University
Study Director: Min-Shan CHEN, Ph.D Sun Yat-sen University
Study Director: Xiao-Jun LIN, Ph.D Sun Yat-sen University
Study Chair: Xiang-Ming LAO, Ph.D Sun Yat-sen University
PRS Account Sun Yat-sen University
Verification Date February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP